Comparing Game Facilitated Interactivity to Genetic Counseling for Prenatal Screening Education

NCT05360095 | Completed

• 2 other identifiers: 00101479R01HG011921
• Study Type: interventional
• Target: 2,045
• Locations: 1 country
• Sites: 3

Brief Summary

Advancements in prenatal genetic screening have significantly improved the identification of chromosomal abnormalities and heritable conditions during pregnancy, yet current standards for patient education in this domain are largely ineffective. The most effective approach to education about prenatal screening is one-on-one genetic counseling, but due to the limited number of counselors this is not feasible, especially in rural and frontier areas. The investigators will address this national problem using a novel education game that can more effectively address this gap in healthcare decision-making.

Conditions

Genetic Counseling; Shared Decision Making; Pregnancy; Genetic Testing; Prenatal Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Prenatal Screening Knowledge

  Knowledge of Prenatal Screening survey determines how well a patient understands important aspects of prenatal genetic screening. It will be adapted from the multidimensional measure of informed choice (MMIC). The knowledge score will range from 0 to 12 with higher scores indicating greater knowledge.

  Baseline (between 6 and 12 weeks gestation), after clinic visit (between 10 and 14 weeks gestation) and at 20 weeks gestation

Secondary Outcomes (2)

• Change in Decisional Conflict

  After clinic visit (between 10 and 14 weeks gestation) and again at 20 weeks gestation

• Shared Decision Making

  After clinic visit (between 10 and 14 weeks gestation)

Study Arms (3)

Usual Care

ACTIVE COMPARATOR

The usual care group will consist of pregnant women who receive no experimental intervention but will receive the brochure-based education about prenatal screening that is currently recommended by American College of Obstetrics and Gynecology (ACOG), delivered in an electronic format, plus any additional clinic materials or oral information provided in conversation with clinicians (n= 375 total, 125 per site). We are transferring ACOG's prenatal screening education onto the electronic platform to control for any differences in attention that may be due to technology platform and to track time interacting with the material via the web portal.

Behavioral: Usual Care

Game Intervention

EXPERIMENTAL

The game intervention group will consist of pregnant women who will interact with the educational intervention also delivered on an electronic platform (n= 375 total, 125 per site). Participants will also receive whatever information is routinely provided in the clinic about prenatal screening such as the brochure and oral information by clinicians.

Behavioral: Meaning of Screening

Genetic Counseling

ACTIVE COMPARATOR

The one-on-one genetic counseling group will receive standard of care for genetic counseling delivered by a board-certified genetic counselor for pre-test education. The counselor will be conducting pre-test education and as with the other study groups, the decision about prenatal screening will be made at the clinical visit with the provider. This group receives also the same clinical materials and oral information by clinicians as the other two groups. Both in-person and tele-health genetic counseling options are available at all sites.

Behavioral: Genetic Counseling

Interventions

Meaning of Screening BEHAVIORAL

The Meaning of Screening game is a decision making tool that is accessible through the most common web platforms. Users have the ability to explore learn about prenatal screening through multiple approaches, including presentation of facts, personal stories, and values clarification. Users will access the game from their personal phone or computer prior to completing prenatal screening.

Game Intervention

Genetic Counseling BEHAVIORAL

This intervention consists of a 45-minute prenatal screening genetic counseling session (in person or online) completed after confirmation of pregnancy and before actual screening.

Genetic Counseling

Usual Care BEHAVIORAL

Participants in the Usual Care group will receive the brochure-based education about prenatal screening that is currently recommended by American College of Obstetrics and Gynecology (ACOG), delivered in an electronic format so they can read it before they complete prenatal screening.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult
• English-speaking people who are attending their first or second OB clinic visit including rural referral centers
• less than 15 weeks pregnant.
• Partner of the pregnant person who speaks English and is an adult
• Able to complete study tasks on a computer or smartphone from home

You may not qualify if:

• already had prenatal screening from this or previous pregnancies,
• have obstetric or family history of chromosomal abnormalities, or genetic high-risk pregnancy and have already met with a genetic counseling about prenatal screening

Sponsors & Collaborators

• Erin Rothwell: lead
• National Human Genome Research Institute (NHGRI): collaborator

Study Sites (3)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Interventions

Genetic Counseling

Intervention Hierarchy (Ancestors)

Genetic Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Erin Rothwell, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Interim Vice President for Research

Model Details: Participants will be recruited and randomized into three different groups, all running in parallel to each other.

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: May 4, 2022
• Study Start: March 7, 2023
• Primary Completion: January 10, 2026
• Study Completion: January 10, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)